CN115515467A

CN115515467A - Attachment for a catheter

Info

Publication number: CN115515467A
Application number: CN202180034520.2A
Authority: CN
Inventors: L·O·舍蒂格
Original assignee: Coloplast AS
Current assignee: Coloplast AS
Priority date: 2020-05-12
Filing date: 2021-05-12
Publication date: 2022-12-23
Also published as: US20230173229A1; EP4149339A1; WO2021228341A1

Abstract

An attachment for assisting in the insertion of a catheter is disclosed. The attachment includes a handle including an attachment means for releasably coupling the catheter to the handle, and a camera for capturing one or more images, and a monitor in communication with the camera is disclosed. The monitor includes a display configured to display one or more images. The attachment provides visualization of the channel region on the monitor by a camera that accompanies movement of the catheter, so as to assist the user in identifying the body passage and inserting the catheter.

Description

Attachment for a catheter

The present disclosure relates to an attachment for assisting in inserting a catheter and a catheter system comprising such an attachment and a catheter.

Drawings

The accompanying drawings are included to provide a further understanding of the embodiments, and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain the principles of the embodiments. Other embodiments, as well as many of the intended advantages of embodiments, will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.

Figure 1 illustrates a perspective view of an attachment according to an embodiment of the present invention,

figure 2 illustrates a perspective view of a handle of an attachment according to an embodiment of the present invention,

figure 3 illustrates a perspective view of a handle of an attachment according to an embodiment of the present invention,

figure 4A illustrates a perspective view of a handle of an attachment according to an embodiment of the present invention,

figure 4B illustrates a representation of a triangle between a first optical axis and a first catheter axis defined by structural features of a handle of an attachment according to an embodiment of the present invention,

figure 5 illustrates a short insertable portion and a long insertable portion of a catheter coupled to a handle of an attachment according to an embodiment of the invention,

figure 6A illustrates a perspective view of a monitor of an attachment according to an embodiment of the present invention,

figure 6B illustrates a perspective view of a monitor of an attachment according to an embodiment of the present invention,

FIG. 7 illustrates a method of using an accessory device according to an embodiment of the present invention, and

fig. 8 shows a schematic view of an attachment according to an embodiment of the invention.

Detailed Description

In the following, various exemplary embodiments and details are described with reference to the drawings when relevant. It should be noted that the figures may or may not be drawn to scale and that elements having similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. Moreover, the embodiments shown do not necessarily have all aspects or advantages shown. Aspects or advantages described in connection with a particular embodiment are not necessarily limited to that embodiment, and may be practiced in any other embodiment, even if not so shown or not so explicitly described.

The present disclosure relates to an attachment for assisting in the insertion of a catheter. In particular, the attachment is suitable for use with intermittent catheters where increased emphasis is placed on avoiding Urinary Tract Infections (UTI). Accordingly, there is a need to be able to easily insert a catheter during a catheterization procedure without contaminating the catheter.

Catheter assemblies for voiding the bladder are increasingly being used for intermittent as well as indwelling or permanent catheterization. Typically, patients with urinary incontinence or disabled persons (like paraplegics or quadriplegia) use urinary catheters, who may lose control of allowing spontaneous urination and for whom catheterization may be the way of urination.

Urinary catheters are divided into two main groups of catheters, namely indwelling catheters and intermittent catheters. Indwelling catheters are typically inserted into the urethra and bladder by medical personnel (i.e. trained professionals, usually nurses or doctors) and have means for retaining the catheter within the bladder for up to two weeks or more. Indwelling catheters are soft and flexible, as they must remain in the urethra for several weeks. The indwelling catheter continuously empties the bladder.

The intermittent catheter is typically inserted by the user himself and remains in the urethra and bladder only for the time it takes to empty the bladder, for example about 5-10 minutes. Intermittent catheters are used every 4-6 hours to empty the bladder, which corresponds roughly to the time interval during which a person without urinary problems usually goes to a restroom. Intermittent catheters are typically more rigid than indwelling catheters because they must be inserted by the user himself, and because they do not require days or weeks of stay in the urethra. An important feature of intermittent catheters is easy insertion into the urethra. This is achieved by providing the intermittent catheter with a low friction surface. Non-limiting examples of this are hydrophilic coated catheters which are subsequently wetted with a swelling medium to form a low friction surface, or wetted with an oil or water-based gel applied to the catheter prior to insertion into the urethra.

Intermittent catheters may be provided with a hydrophilic coating that needs to be wetted before use and thereby absorb large amounts of liquid. Such a hydrophilic coating will provide a very smooth surface with very low friction when inserted into a catheter. Hydrophilic coated catheters (where the coating absorbs large amounts of liquid to obtain a low friction surface) (> 100%) are not suitable for use as indwelling catheters because the hydrophilic surface coating will stick within the urethral mucosa if left in the body for a longer period of time, as the hydrophilic coating changes from a highly lubricious state when fully wetted to being tacky when the hydration level of the coating is reduced.

The attachment as disclosed herein is particularly suitable for use with an intermittent catheter inserted by the user himself or herself.

In the following, whenever reference is made to the proximal end of an element, this refers to the end adapted to be inserted. Whenever reference is made to the distal end of an element, it is referred to the end opposite the insertion end. In other words, the proximal end is the end closest to the user when the catheter is to be inserted, while the distal end is the opposite end (the end furthest from the user when the catheter is to be inserted).

The longitudinal direction is the distal to proximal direction. The transverse direction is a direction perpendicular to the longitudinal direction, which corresponds to a direction transverse to the axis of the conduit.

In the following, whenever reference is made to a device being "releasably coupled" to another device, it is to be understood that these devices may be temporarily attached so as to minimise the risk of their accidental separation. However, these devices should be attached so that they can be separated if desired.

A catheter, particularly an intermittent urinary catheter, suitable for use with an attachment according to embodiments disclosed herein comprises a main tubular portion extending from a distal end to a proximal end. The tubular portion may be cylindrical or conical. In an embodiment, the tubular portion has an elliptical cross-section. The tubular portion is configured to provide a flow of urine through the intermittent catheter from the discharge portion to the distal end. A closed end portion having a closed tip is positioned at the proximal end of the conduit and is configured as a circular closed end of a tube that forms the main tubular portion of the conduit. The discharge portion of the tubular portion will typically be in the proximal portion of the tubular portion. In an embodiment, the discharge portion comprises a plurality of discharge openings to provide for flow of urine between the exterior of the catheter and the lumen of the tubular portion. The catheter may comprise a connector in the distal end and in embodiments may comprise a flared end of the catheter, such that the diameter of the connector is increased relative to the tubular portion. The connector may serve as a handle that allows a user to manipulate the catheter, and/or the catheter may include a handle at the distal end having a length that allows a user to manipulate the catheter. The catheter includes an insertable portion adjacent the connector and/or handle, the insertable portion extending from the proximal tip to the connector.

Catheters commonly used as urinary drainage devices are 8FR codes to 18FR codes. FR (or french size or Charriere (Ch)) is a standard gauge of a catheter, approximately corresponding to the periphery in mm. More precisely, the outer diameter of the catheter in mm corresponds to FR divided by 3. Thus, 8FR corresponds to a catheter having an outer diameter of 2.7mm, while 18FR corresponds to a catheter having an outer diameter of 6 mm. Catheters used with the presently disclosed accessory devices may be provided with a hydrophilic coating prior to use in order to impart low friction insertion.

A catheter particularly suitable for use with an attachment according to the present disclosure may be a female intermittent urinary catheter comprising an insertable portion of between 55mm and 200mm in length. For example, one type of female intermittent urinary catheter may be a compact catheter having an insertable portion with a length between 55mm and 80mm, another type may be a straight catheter having an insertable portion with a length between 140mm and 200mm, and an intermediate type may be a catheter having an insertable portion with a length between 80mm and 140 mm.

Although the above discussion relates to urinary catheters, in particular intermittent urinary catheters, it is envisaged that the attachment arrangement described herein may also be used with other types of catheters, in particular catheters that are inserted by the user himself or herself, such as anal catheters for use with intestinal irrigation systems, or whenever a catheter may need to be inserted, in particular in situations where it is difficult to identify the body passage for different reasons.

The use of the word "substantially" in this disclosure as a modifier of certain features or effects is intended to simply indicate that any deviation is within the tolerance normally expected by a person skilled in the relevant art.

The use of the word "substantially" as a modifier of certain features or effects in this disclosure is intended merely to indicate that with respect to structural features: most or a major part of this feature exhibits the discussed property and is intended to mean for a functional feature or effect: most results relating to this property provide this effect, but anomalous results do not.

The present disclosure provides an attachment for assisting in the insertion of a catheter and a catheter system for assisting in the insertion of a catheter.

In a first aspect, an attachment for assisting in the insertion of a catheter is disclosed. The attachment includes: a handle comprising attachment means for releasably coupling (such as receiving and releasably coupling) the catheter to the handle, and a camera for capturing one or more images: and a monitor in communication with the camera. The monitor includes a display configured to display one or more images.

For some people, inserting a catheter (such as an intermittent urinary catheter) may be difficult for different reasons, including difficulty in seeing and/or identifying body passages in the passage area, e.g. due to the presence of skin folds, excessive skin, etc. Further, in order to avoid Urinary Tract Infections (UTI), it is recommended that the catheter be inserted without contacting the surrounding channel region and contaminating the sterile insertable part. The problems described herein are particularly evident for women, but the attachment can be used with catheters that are adapted for both men and women.

The present embodiments provide a handheld attachment for visualizing a passage area on a monitor by a camera moving along with a catheter, so as to help a user identify a body passage and insert the catheter. In particular, a handheld and portable accessory device is provided that is easy to use, allowing a user to carry the device with him and use it during each catheterization.

Embodiments provide an attachment having a handle configured to receive a catheter such that the catheter may be coupled/attached to the handle. In particular, the attachment means of the handle is configured to releasably couple the catheter to the handle. For example, the attachment tool may receive a connector of a catheter. Further, the handle comprises a camera for capturing one or more images, preferably of the proximal end of the catheter coupled to the handle and its surroundings (e.g. the passage area when the catheter and the handle are close). In an embodiment, the camera is substantially longitudinal (e.g. along the optical axis) and may have a diameter (e.g. of the lens of the camera) of less than 15mm, such as less than 10mm, such as in the range of 3mm to 8mm, in order to provide a compact handle. The camera may be any commercially available camera suitable for the intended use. In an embodiment, the camera comprises an image sensor, such as a CCD sensor or a CMOS sensor.

In a preferred embodiment, the camera is configured to capture a plurality of images, such as to form a video. In an embodiment, multiple images are captured (by a camera) and displayed (on a display) in succession to form a video (e.g., having a frame rate of at least 20 FPS). Further, preferably, the video is transmitted/broadcast to the display of the monitor without delay, in order to provide a live video clip of the object within the field of view of the camera. Thus, the movement caused by the user manipulating the handle is reflected in the image/video displayed in the display. Thus, the user can control/steer the catheter by holding the handle and moving the handle according to what he/she sees on the monitor. Therefore, the user can recognize the body duct on the display and easily insert the catheter based on the image/video of the monitor. In particular, the user may guide the tip of the catheter into the body passage by viewing the tip of the catheter on the display. When the user has inserted the catheter into the body passage (e.g., under guidance of the displayed image/video), he/she may keep the handle coupled with the catheter during urination/evacuation, or he/she may decouple the catheter from the handle and continue urination/evacuation.

In an embodiment the handle has a substantially rectangular cross-section with sides no more than 50mm long in order to provide a small handheld device. In an embodiment, the handle is made of a plastic material and/or a metal, such as aluminum. In an embodiment, the handle is formed in an injection molding process or a 3D printing process. In embodiments, the handle includes an organically shaped body, such as to provide an ergonomic grip.

In an embodiment, a monitor includes a housing having a front including a display, and a rear. In an embodiment, the housing is made in an (injection) molding process or a 3D printing process. In an embodiment, the monitor comprises a power supply unit, such as a battery, for powering the display. In an embodiment, the camera and the optional light source are powered by a power supply unit of the monitor. In an embodiment, the handle comprises a power supply unit, such as a battery, for powering the camera. In an embodiment, the monitor comprises a processor for processing images captured by the camera and for displaying the images on the display. In an embodiment, the monitor comprises a memory, such as a volatile memory, such as a Random Access Memory (RAM). In an embodiment, the monitor comprises a power button for switching on the monitor (and its display) and/or the camera. In an embodiment, a power button turns on the monitor and camera so that the accessory device is ready for use in a single action. In an embodiment, the monitor and/or handle includes a charging port, such as a waterproof or watertight charging port, coupled to the battery. In an embodiment, the charging port is of the USB type. In an embodiment, a charging port is connected to the power supply unit and the processor, such as to provide firmware for updating the processor. In an embodiment, the monitor and/or handle includes means for wireless charging, such that the monitor and/or handle may be wirelessly charged, for example, to reduce the risk of water affecting the function of the accessory device.

In an embodiment, the monitor (such as its processor) is configured to mirror one or more images in the display. Thus, the handle is visually displayed in the display based on movement of one or more images (e.g., caused by the user). In other words, by mirroring the image in the display, movement of the handle in a particular direction is reflected by movement in the same particular direction in the display. Thus, the user can more easily understand the movement he/she causes of the handle and the catheter coupled to the handle.

In an embodiment, the display is a conventional display suitable for the disclosed use. For example, the display may be an LCD display or an LED display. In an embodiment, the size of the display is between 1 "and 5" (inches diagonal), such as to provide a small monitor that is easily portable. In embodiments, the display has a size of 1", or 2", or 3", or 4", or 5", or greater than 5". In an embodiment, the display is touch sensitive, such as to provide for detecting touch gestures, such as pinching to zoom in on an image or turning on/off a light source.

In an embodiment, the accessory device has a liquid ingress protection rating of at least IPX4 according to IEC standard 60529. For example, the accessory device may have a liquid ingress protection rating of IPX4, or IPX5, or IPX6, and/or IPX7, and/or IPX 8. Increasing the grade allows for increasing the general use of the attachment, such as providing a washable attachment to clean the device in liquid/water, such as after use. Further, the liquid ingress protection rating provides protection for the accessory device during catheterization procedures where exposure to liquids such as urine is a possible consequence. In an embodiment, at least the handle of the accessory device has a liquid ingress protection rating according to the embodiments described above.

In an embodiment, the attachment means comprises a clip for releasably coupling the connector of the catheter to the handle. Thus, the insertable part of the catheter remains sterile and is not restricted by the attachment tool or the handle itself, such that the insertable part extends into the free space along the first catheter axis, as will be discussed below. Further, since the insertable portion is typically provided with a coating that provides low friction, merely coupling the connector to the handle provides an easy attachment-a user can hold the connector and couple it to the handle without contacting the sterile insertable portion.

In an embodiment, the clip is configured to receive a cylindrical or conical portion, such as a cylindrical or conical portion of a connector, which has a diameter of less than 15mm, such as in the range of 5mm to 15mm, such as between 8mm and 13 mm.

In embodiments, the clip comprises one or more flexible elements, such as elements supported by springs and/or resilient materials, such that the catheter may be coupled to the clip by manipulating/actuating the flexible elements. In an embodiment, the flexible element is made of a plastic material, such as a rigid plastic material supported by springs and/or a rubber material.

In an embodiment, the clip is configured to secure the connector of the catheter by friction. In an embodiment, the clip includes a conical interior shape configured to receive and secure a connector of a catheter in a sliding motion.

In an embodiment, the clip is a rigid (e.g. made of a plastic material) cylindrical or conical part (or a part thereof) having an inner curvature corresponding to the outer curvature of the catheter (such as its connector), adapted to the given inner curvature of the clip. Thus, the clip may receive the catheter in a sliding motion, wherein the user slides the catheter (e.g., its connector) into the clip. Thus, the clip according to embodiments provides for securing the catheter by friction. Also, the user may remove the catheter by sliding the catheter in the opposite direction. The conical interior shape provides for increased friction between the connector and the clip as the user slides the connector into the clip. Thus, the connector and thus the catheter is secured in the clip in such a way that the catheter can still be removed by the user pulling the catheter in the opposite direction by overcoming the force of friction. The conical inner shape may be provided for using different types of catheters, as long as these catheters have suitable connectors: the increased friction provides adequate securing of the different catheters to the clip.

In an embodiment, the attachment means, e.g. in the form of a clip, is integral with the handle, such that the handle including the attachment means may be manufactured in a single (injection) moulding process or a 3D printing process. According to such a manufacturing process, the camera may then be positioned, for example, mounted (e.g., adhered) in a recess of a handle formed in a molding or printing process.

In an embodiment, the attachment means is steerable, such as tiltable, relative to the body of the handle and/or the camera, e.g. by a hinge portion, such that a user can tilt the attachment means relative to the camera, for example. In an embodiment, the tiltable attachment tool is lockable relative to the body of the handle, such that when a user has tilted the attachment tool to a desired position, the user can lock the attachment tool in this desired position. Thus, the user may tilt the attachment means such that the catheter coupled to the attachment means extends along a certain first catheter axis, as will be described below.

In an embodiment, the camera is steerable, such as tiltable, for example by a hinged portion relative to the body of the handle and/or the attachment means, such that a user can tilt the camera relative to the attachment means, for example. In an embodiment, the tiltable camera is lockable relative to the body of the handle, so that when the user has tilted the camera to a desired position, the user can lock the camera in this desired position. Thus, the user may tilt the camera such that the camera has a certain viewing direction with respect to a certain first catheter axis of the catheter coupled to the attachment means, as will be described below.

By providing attachment means and/or a camera that are manipulable relative to each other, for example, a user may adjust the attachment device according to the catheter he/she prefers to use, e.g., so that the camera is directed at a desired object, such as the tip of his/her preferred catheter. In an alternative embodiment, as will be described in more detail below, the camera and attachment tool are fixed relative to the handle and relative to each other. However, according to such embodiments, as will be apparent from the following, the first optical axis of the camera may intersect the first catheter axis of the catheter to provide a universal attachment suitable for use with a range of different catheters without the need to adjust the attachment tool and camera prior to use.

In an embodiment, the attachment tool is configured for securing the catheter along the first catheter axis. In an embodiment, the attachment tool defines a first catheter axis. In an embodiment, the first catheter axis coincides with a longitudinal direction of a catheter (in particular an insertable part of the catheter) coupled to the attachment tool.

Thus, the first catheter axis is the axis along which the catheter coupled to the attachment tool extends. In a preferred embodiment, the attachment means provides for fixing the catheter relative to the handle and/or camera such that the catheter is securely coupled to the handle, for example by the above disclosed embodiments of the clip. Thus, the catheter is fixed to the handle and will extend along the first catheter axis.

In an embodiment, the camera is fixed relative to the attachment tool. By fixing the camera and the attachment means relative to each other, e.g. in/on a handle, the user can manipulate a catheter coupled to the attachment means and see the corresponding motion captured by the camera on the monitor. In other words, by the camera and the catheter coupled to the attachment tool being fixed relative to each other, the camera and the catheter coupled to the attachment implement move concomitantly as the user manipulates the handle to provide a stable image of the catheter and the tunnel region.

In an embodiment, the viewing direction of the camera is directed towards the tip of the catheter coupled to the attachment tool such that the tip is substantially centered in the image captured by the camera. In an embodiment, the tip is offset from the center of the image captured by the camera to provide a larger image of the channel region, such as on a display of the monitor.

In an embodiment, the camera comprises a first optical axis defining a viewing direction. Thus, it can be said that the camera is "pointing" in a direction which is the viewing direction defined by the first optical axis of the camera. In an embodiment, the center of the field of view of the camera coincides with the first optical axis. The first optical axis defines a viewing direction. Thus, objects within the field of view, particularly objects near the first optical axis, are captured by the camera into an image.

In an embodiment, the first optical axis intersects the first catheter axis. Thus, an object (e.g., a catheter) arranged along the first catheter axis, such as a portion thereof (e.g., a tip of the catheter), may be captured in an image by the camera. The intersection point can be created by designing the handle appropriately so that the attachment tool provides a coupled catheter angled relative to the camera; in other words, the first catheter axis is at an angle relative to the first optical axis, the angle providing an intersection between the axes. In an embodiment, the angle is between 10 and 30 degrees, such as between 15 and 25 degrees.

In an embodiment, the first optical axis intersects the first catheter axis at a distance between 55mm and 200mm from the lens of the camera. A fixed reference point is provided by measuring from the lens of the camera, instead of from the image sensor of the camera. Alternatively, the distance may be measured from the proximal end of the attachment means, which is the portion of the attachment means closest to the tip of the coupled catheter. In an embodiment, the proximal end of the attachment tool may be flush with the distal end of the insertable portion of the catheter such that the distance from the proximal end of the attachment tool to the tip of the catheter corresponds to the length of the insertable portion of the catheter. In particular, by measuring from the lens of the camera, deviations due to the use of different types of catheters and accessories are avoided. Although small deviations from the triangular representation of the handle and corresponding axis may occur, it will be appreciated that providing the intersection at a distance from the lens of the camera (e.g., the distance corresponding to the length of the insertable portion of the catheter) will in most cases allow the tip of the catheter to be located within the field of view of the camera. Alternatively, the intersection measured from the lens of the camera may be reduced by a factor depending on the distance between the camera and the attachment means of the handle and on the length of the insertable part of the catheter coupled with the catheter. The triangular deviations supported by the figures are provided in the detailed description of the figures.

Providing a point of intersection at a distance between 55mm and 200mm from the lens of the camera allows the attachment to be used with female intermittent catheters commonly used on site.

In an alternative embodiment, the first optical axis intersects the first catheter axis at a distance of between 55mm and 200mm from any portion of the handle, thereby providing some free space between the handle and the tip and channel region of the catheter.

By intersecting the first catheter axis and the first optical axis, it is provided that the tip of the catheter is within the field of view of the camera. For example, where a user prefers to use a catheter that can be inserted 100mm in length, the handle can be designed to have a point of intersection at 100mm from the camera lens, thereby ensuring that the tip of the catheter is within the field of view of the camera.

In an embodiment, the attachment is optimized for a class of female intermittent catheters. For example, an accessory device suitable for use with a compact catheter (insertable portion length 55mm to 80 mm) may have a point of intersection at a distance between 55mm and 80mm from the lens of the camera, such as at 67.5 mm. For example, an attachment suitable for use with a straight catheter (insertable portion length 140mm to 200 mm) may have a point of intersection at a distance between 140mm and 200mm from the lens of the camera, such as at 170 mm. For example, an attachment suitable for use with an intermediate catheter (insertable portion length 80mm to 140 mm) may have a point of intersection at a distance between 80mm and 140mm from the lens of the camera, such as at 110 mm.

In an embodiment, the camera has a (e.g., fixed) focus distance corresponding to a distance from a lens of the camera to an intersection between the first optical axis and the first catheter axis, where the focus distance refers to a distance from the camera lens to a best focus of the camera. Preferably, the best focus is located at the tip of the catheter coupled to the handle such that the focus distance corresponds to the distance from the camera lens to the tip of the catheter. Thus, a catheter tip arranged in the intersection between the first optical axis and the first optical axis will be focused in the image generated by the camera.

In an embodiment, the camera comprises means for autofocusing, such as means for detecting and autofocusing on the tip of the catheter, thereby providing focusing on the tips of catheters of different lengths.

In an embodiment, the camera has a depth of field of at least 60mm. As generally defined, the depth of field (DoF) is the distance between the nearest and farthest objects in an image that are in acceptable sharp focus. A particular DoF can be provided by appropriately designing the optics of the camera (e.g., by selecting appropriate values for focal length, aperture size, and acceptable circle of confusion size, and distance to the object to be focused).

A camera with a DoF of at least 60mm provides a wide range of different catheters with insertable portions of different lengths and provides simultaneous focusing of the tip of the catheter and its vicinity, such as the channel region. For example, a 60mm DoF provides for the use of catheters that vary in length up to 60mm without defocusing the tip of such a given catheter, as long as the above-mentioned intersection points between the first optical axis and the first catheter axis intersect at an appropriate distance from the lens of the camera (or other reference point on the handle). For example, in an embodiment where the point of intersection between the first optical axis and the first catheter axis is 110mm from the camera lens and the DoF is at least 60mm, the attachment may be used with catheters that are insertable within a length range of 110mm +/-30mm (i.e. from 80mm to 140 mm) so that the tips of the catheters will all be within the focal point of the camera (here ignoring minor deviations from the choice of reference points). Further, doF focuses the surrounding environment, such as the tunnel region and/or body duct, and the tip of the catheter simultaneously, so that the image displayed in the display adequately visualizes the tip and the tunnel region.

In an embodiment, the camera has a DoF between 10mm and 150mm, such as between 20mm and 100mm, such as between 30mm and 90mm, such as between 40mm and 70mm, such as 40mm, 50mm, 60mm or 70mm.

In an embodiment, the camera has a DoF of maximum 10mm, e.g. to provide a particularly sharp image of the tip end of the catheter, e.g. if the attachment is particularly optimized for a certain type of catheter.

In an embodiment, the minimum focus distance of the camera is 55mm maximum (i.e., 55mm or less) so that the camera can focus objects down to 55mm from the lens of the camera (e.g., the tip of a compact catheter).

In an embodiment, the accessory device further comprises a light source. In an embodiment, the light source is arranged in the handle. In embodiments, the light source may be attached to the handle and/or the monitor. In an embodiment, the light source is arranged in the monitor. In an embodiment, the light source is connected to a power supply unit (e.g. a battery) of the monitor, or to a power supply unit (e.g. a battery) of the handle. In an embodiment, the light source comprises one or more LEDs (diodes), such as a plurality of LEDs, such as a plurality of white LEDs.

In an embodiment, the light sources are arranged circularly around the camera, such as around a lens of the camera. Thus, the light source may illuminate an object arranged along the first optical axis of the camera. In an embodiment, the plurality of LEDs are arranged circularly around the camera. Thus, the plurality of LEDs may be arranged circularly around the first optical axis of the camera.

In an embodiment, the light source is configured to generate a light beam substantially parallel to a first optical axis of the camera. In an embodiment, the light beam substantially coincides with the first optical axis of the camera. In an embodiment, the light beam is a component light beam comprising a plurality of elemental light beams generated by a plurality of individual LEDs. In an embodiment, the light beam converges towards an intersection between the first optical axis and the first catheter axis. In an embodiment, the light beam is divergent. In an embodiment, the light beam is substantially parallel to and coincident with the first optical axis of the camera. In an embodiment, a parallel, converging or diverging light beam may be formed by suitably arranging a plurality of LEDs around a first optical axis and angling them.

The benefits of using the disclosed accessory device are further enhanced by providing a light beam configured to illuminate the tip of a catheter coupled to the handle and particularly to illuminate areas of the surrounding environment, such as areas of a passageway.

In an embodiment, the monitor comprises a strap for securing the monitor to an object, such as a leg of a user. Thus, the monitor may be supported by the object so that the user may free his/her hands to manipulate the handle with the catheter. In an embodiment, the strap is elastic and flexible such that the strap can be comfortably disposed around the leg of the user. In an embodiment, the strap includes a fastening means, such as a buckle or hook and loop fastener for securing the strap tightly to an object. In an embodiment, the strap is attached to the rear of the monitor such that a display arranged at the front of the monitor is visible to the user. In an embodiment, the strap is attached to the hinge element of the monitor such that the user can rotate/tilt the monitor relative to the strap and thus relative to the object/leg, e.g. to provide a comfortable viewing angle for the user. In an embodiment, the rear of the monitor includes a protrusion, e.g., a coupling mechanism as discussed below, for providing a natural tilt of the monitor when the monitor is secured to an object/leg.

In an embodiment, the monitor comprises a coupling mechanism for releasably coupling the handle to the monitor. Thus, the handle may be easily stowed, for example for storage and transport. In an embodiment, the coupling mechanism is a receptacle or a protrusion. In an embodiment, the coupling mechanism is a protrusion engageable with an attachment means of the handle such that the handle can be coupled to the monitor via the attachment means. For example, the protrusion may have an outer shape that corresponds to the inner shape of the attachment tool, such that the attachment tool, and thus the handle, may be coupled to the monitor in the same manner as the catheter is coupled to the attachment tool.

In an embodiment, the monitor comprises a recess or groove arranged between the front and the back of the monitor, the recess or groove extending circumferentially around the monitor forming a cable reel for storing a strap and/or cable of a camera connecting the monitor and the handle.

In an embodiment, the monitor communicates with the camera through a wired connection. In other words, in an embodiment, a cable connects the monitor and the camera of the handle (and optionally the light source of the handle). The cable is configured to power the camera, and optionally the light source, and to transmit image data from the camera to the monitor. Thus, the accessory device relies on a physical/wired (as opposed to wireless) connection between the monitor and the camera. Thus, accessory devices such as cameras and/or monitors are protected from wireless interruptions and/or unauthorized hacking. Thus, the wired connection is reassuring to the user, ensuring that the image captured by the camera is not intercepted by a (unauthorized) third party/intermediary.

In an embodiment, the handle comprises a first interface for receiving a cable and the monitor comprises a second interface for receiving a cable. In an embodiment, the cable is releasably coupled to the handle and/or the monitor such that the handle, the cable and the monitor can be disconnected from each other in the first interface and the second interface, such as for storage. In an embodiment, the cable is mounted to the first and second interfaces, such as to avoid accidental disconnection and to avoid the need to assemble the accessory device prior to use.

According to an alternative embodiment, the monitor communicates with the camera through a wireless connection. According to such embodiments, the handle (e.g. its interface) and the monitor (e.g. its interface) each comprise an antenna and a wireless transceiver for exchanging data, in particular image data indicative of images captured by the camera. The transceiver of the handle provides wireless pairing with the transceiver of the monitor and vice versa. In an embodiment, the handle is configured to transmit a signal indicative of an image captured by the camera to the monitor. The wireless transceiver may be a bluetooth transceiver, i.e., the wireless transceiver may be configured for wireless communication according to a bluetooth protocol (e.g., bluetooth low energy technology, bluetooth 4.0, or bluetooth 5).

In a second aspect, a catheter system for assisting in inserting a catheter is disclosed. The catheter system includes an attachment and a catheter including an insertable portion having a proximal end and a connector. The attachment device includes: a handle comprising an attachment means for releasably coupling the catheter to the handle, and a camera for capturing one or more images; and a monitor in communication with the camera, the monitor including a display configured to display one or more images.

In an embodiment, the catheter is a urinary catheter, such as an intermittent urinary catheter insertable in a length of between 55mm and 200mm, such as between 80mm and 140 mm. In an embodiment, the catheter is an anal catheter for anal irrigation, such as an anal catheter having an outer diameter of between 8mm and 16mm (such as 10 mm) and a length of between 70mm and 200 mm.

The catheter system incorporates an attachment according to the first aspect, and it will be appreciated that the embodiments and their associated benefits apply to the disclosed catheter system.

In an embodiment, the camera is configured to focus at the proximal end of the catheter. Thus, the proximal end (tip) of the catheter coupled with the attachment tool and thus with the handle is focused in the image(s) sent to and displayed on the monitor's display.

In a third aspect, a method of using a catheter system is disclosed. The method comprises the following steps: optionally, the handle is decoupled from the monitor, the catheter is coupled to the handle, and images captured by the camera are viewed on a display of the monitor to locate the tunnel region and the body duct and guide the catheter proximate thereto. In an embodiment, the method further comprises inserting a catheter into the body passage.

In embodiments, such as in a transport configuration, the handle is coupled to (the rear of) the monitor, and as such, the method may comprise the optional step of decoupling the handle from the monitor. In an embodiment, coupling the catheter to the handle comprises coupling the connector of the catheter to the attachment tool according to the previous embodiment, such as coupling the connector to the attachment tool in a sliding motion, wherein the connector is frictionally secured to the attachment tool. In an embodiment, the viewing of the images on the display of the monitor is provided by a camera of the handle capturing images, in particular images of the tip/proximal end of the catheter, which are transmitted to the display. By viewing the image of the display, so that the image visualizes the tip of the catheter and its vicinity (e.g., the channel region), the user can manipulate/guide the handle so that the channel region is within the field of view of the camera. Thus, from the images, the user can locate the passageway region and the body tract, and further, by appropriately manipulating/guiding the handle, guide/bring the catheter close to the body tract so that the user can insert the catheter into the body tract. In embodiments, the method further comprises decoupling the catheter from the handle, such as before or after urination/voiding. In an embodiment, the catheter is decoupled from the handle according to the previous embodiments, such as by a sliding motion, wherein the user provides a force that overcomes friction between the connector of the catheter and the attachment tool.

Detailed description of the drawings

Fig. 1 illustrates a perspective view of an attachment 100 coupled to a catheter 10. The attachment 100 includes a handle 110 and a monitor 120. The handle 110 includes an attachment means 111 for releasably coupling the catheter 10 to the handle, and a camera 112 for capturing one or more images. The camera 112 and the monitor 120 are connected by a wired connection via a cable 121. The body 113 of the handle 110 may have a curved shape, for example, to provide an ergonomic grip for a user's hand.

In the illustrated embodiment, the catheter 10 (dashed line) is coupled to an attachment tool 111. The attachment tool 111 secures the catheter 10 along the first catheter axis L. The first catheter axis L defines the longitudinal direction of the catheter 10. The first catheter axis L may be defined by suitably designing the attachment means 111 such that it can repeatedly (i.e. each time) fix the catheter 10 along the same axis, i.e. the first catheter axis L.

The catheter 10 according to the illustrated embodiment includes: an insertable portion 11 having a proximal end forming a tip 12 of the catheter 10; and a connector 13 disposed distal to the insertable portion 11. According to the illustrated embodiment, the catheter 10 is coupled to an attachment means 111 of the handle 10 by a connector 13 (see also fig. 3). Thus, the insertable part 11 remains sterile and extends into the free space along the first catheter axis L.

The camera 112 is arranged in the handle 110 so as to be fixed relative to the handle 110 and the attachment means 112. The camera 112 comprises a first optical axis K defining a viewing direction of the camera. In other words, the camera 112 is capable of capturing one or more images of the object and its surroundings intersecting the first optical axis K according to the field of view. The attachment means 111 and the camera 112 are arranged in the handle and separated by a distance, for example 10mm to 30mm, such as 20mm. Further, the attachment tool 111 and the camera 112 are angled relative to each other so that the first catheter axis L intersects the first optical axis K at the intersection point P. In other words, the handle 110 is designed such that the first catheter axis L intersects the first optical axis K. In the illustrated embodiment, handle 110 is designed such that point of intersection P is aligned with tip 12 of catheter 10. Thus, the tip 12 will be centered in the image captured by the camera 112, and thus in the center of the display 122 of the monitor 120.

The monitor 120 is connected to the handle 110, in particular to the camera 112 of said handle, by a cable 121. In an alternative embodiment, the monitor 120 and camera 112 are wirelessly connected. The monitor 120 includes a display 122 configured to display one or more images captured by the camera 112. One or more images are transmitted from the camera 112 to the monitor 120 and then displayed on the display 122. In a preferred embodiment, the camera 112 captures multiple images in succession to form a video that is transmitted to the display 122 without delay in order to form a live video/clip of objects within the field of view of the camera 112. In the illustrated embodiment, the tip 12 'of the catheter 10 is displayed with the body passage 94' corresponding to an object within the field of view of the camera 112.

Fig. 2 illustrates a perspective view of an embodiment of the handle 110 of the attachment 100. The handle 110 comprises an attachment means 111 and a camera 112 arranged in the handle 110. The body 113 of the handle 110 may have a curved shape in the direction from the attachment means 111 to the camera 112, for example to provide an ergonomic grip for the user's hand. In the embodiment shown, the curved shape is such that there is a thinner portion between the camera 112 (the portion of the handle 110 holding the camera) and the attachment tool 111. The user may prefer to grasp the handle 110 with his/her thumb and forefinger, and this may be made easier by providing a thinner portion between the portion holding the camera and the attachment means.

The attachment tool 111 according to the illustrated embodiment comprises a cylindrical portion 114 having a slit 115 for easy insertion of a catheter into the attachment tool 111. The cylindrical portion 114 may have an inner conical curvature 114 '(illustrated by dashed lines) narrowing towards the proximal end 111a of the attachment means 111 to provide fixation of the catheter, such as by a sliding motion, wherein the user slides the connector of the catheter along the first catheter axis until friction between the connector and the inner conical curvature 114' of the cylindrical portion 114 causes the connector, and thus the catheter, to be (releasably) fixed/coupled to the attachment means 111. In embodiments, some portions of the cylindrical portion 114 are resilient and/or flexible, e.g., supported by a spring or an elastic material, such as to provide a secure grip on the catheter (e.g., a connector thereof).

The light sources 116 are arranged circularly around the camera 112. According to the illustrated embodiment, the light source 116 comprises a plurality of LEDs 116' arranged circularly around the camera, such as around the first optical axis of the camera 112. The light source 116 may be powered by the handle 110 and/or a power supply unit of the monitor, such as by a cable 121 extending from the handle 110 to the monitor (not shown). The light source 116 is configured to generate a light beam substantially parallel to a first optical axis of the camera 112 such that an image captured by the camera 112 is illuminated by the light source 116.

Fig. 3 shows an embodiment of the handle 110 according to fig. 2, wherein the catheter 10 (dashed line) is coupled to the attachment means 111. In particular, the connector 13 of the catheter 10 is coupled to the attachment tool 111 as described with respect to fig. 2. The catheter 10 is fixed by the attachment means 111, whereby the catheter extends along a first catheter axis L. Thus, the longitudinal direction of the catheter 10 coincides with the first catheter axis L. Further, the first optical axis K of the camera 112 extends such that it intersects the first catheter axis L at an intersection point P (here, the intersection point coincides with the tip 12 of the catheter 10). Thus, the tip 12 of the catheter 10 is ensured to be within the field of view of the camera 112 so that when the handle 110 brings the catheter 10 close to a channel region, the camera 112 can capture images (e.g., to form a video) of the tip 12 and its vicinity (such as such a channel region).

Fig. 4A illustrates an embodiment of the handle 110, wherein the first catheter axis L and the first optical axis K are indicated by vectors/arrows. The first catheter axis L intersects the first optical axis K at an intersection point P. The first optical axis K and the first catheter axis L are initially (i.e., in the handle 110) separated by a spacing S. To describe this case in a triangular manner, the first optical axis K and the interval S according to the embodiment form a right angle.

Fig. 4B illustrates a triangular representation of the relationship between the first optical axis K and the first catheter axis L, as defined by structural features of the handle 110. The triangle representation is based on the embodiment of the handle 110 shown in fig. 4A.

To accommodate a wide range of different catheters, in particular catheters having different (insertable) lengths, and to focus the channel region and the tip of the catheter simultaneously, the camera may be designed with a certain depth of field (DoF). By having a suitable DoF, the exact point of intersection P between the optical axis K and the catheter axis L does not limit the function of the attachment. Rather, doF also provides for focusing shorter or longer catheters while providing for focusing the channel region when the tip of the catheter is near the channel region.

The following deviations should not be considered to limit the scope of the present invention. Rather, this deviation is intended to clarify and emphasize how a DoF may be appropriately selected to allow an attachment according to embodiments of the present disclosure to be used with a wide range of different catheters. Thus, although the assumptions provided herein are based on a triangular representation according to fig. 4B, it should be understood that different representations may be more appropriate for an attachment according to embodiments of the present disclosure.

In general, the required DoF can be calculated as

DoF＝K _max -K _min

Wherein, K _max Is the desired maximum focus distance (distance from the camera lens to the object to be focused), and K _min Is the minimum required focus distance. K is _max And K _min This can be calculated by applying a trigonometric function to the triangular representation of fig. 4B:

wherein a right triangle is assumed (see fig. 4B), and wherein S is the interval between the optical axis K in the handle and the catheter axis L (corresponding to the shorter side of the triangle), L _max Is attached to the bookMaximum insertable length of catheter with which the device is used, and L _min Is the minimum insertable length of catheter used with the present attachment.

For example, assuming a spacing S of 20mm and assuming that the attachment is configured to accommodate catheters having an insertable length in the range 80mm to 140mm, the required DoF is 61mm (preferably larger to account for deviations from the applied triangular representation). Assuming a spacing S of 30mm, the corresponding DoF is 63mm, and for S =10mm, the corresponding DoF is 60mm.

Thus, the above-described deviations indicate that if the DoF of the camera has been designed to be about 60mm, the attachment can be effectively used with a catheter having an insertable portion with a length in the range of 80mm to 140 mm.

The DoF of the camera can be designed by selecting appropriate parameters/optical elements of the camera, e.g. by selecting appropriate values for the focal length, aperture size and acceptable circle of confusion size.

By designing a specific DoF, the camera is allowed to focus the tip of the catheter, regardless of the insertable length of the catheter (within the limits discussed). Thus, the first optical axis of the camera and the first catheter axis need not intersect exactly at the catheter tip used to focus said tip.

Fig. 5 shows a short insertable portion 11a (dashed line) of the catheter coupled to the attachment tool 111, which is stacked with a long insertable portion 11b (solid line) (connector not shown). As the attachment tool 111 secures the catheter along the same first catheter axis L, the first catheter axis L of each of the two

insertable portions

11a, 11b coincide. The first optical axis K intersects the first catheter axis L at an intersection point P disposed at a point along the first catheter axis L between the tip 12a of the short insertable portion 11a and the tip 12b of the long insertable portion 11 b. As shown, the camera has a DoF covering each of the

heads

12a, 12b and the intersection point P. Thus, the tip 12a of the short insertable portion 11a and the tip 12b of the long insertable portion 11b are both in the focal point of the camera 112. Thus, the image generated by the camera is focused on both catheters, so that the user can choose to use either catheter without risking poor image quality due to the tip of his/her preferred catheter being out of focus. Further, when a catheter coupled to the handle is close to the passage region, the DoF also allows the passage region to be in focus.

Fig. 6A illustrates a perspective view of a monitor 120 of an accessory device according to an embodiment of the present disclosure. The monitor 120 includes a front 120a and a back 120b. The front 120a of the monitor 120 includes a display 122 configured to display images captured by the camera of the accessory device. The display 122 may be a commercially available display such as an LED display or an LCD display.

The monitor 120 may comprise a power supply unit, such as a battery, for powering the display and/or the camera of the handle, and optionally a light source. The monitor 120 may include a charging port for charging the battery. The monitor 120 may include a processor for processing images captured by the camera of the accessory device and/or for manipulating the display of images.

The groove 124 may be disposed circumferentially around the monitor 120, such as between the front 120a and the back 120b, such as to form a cable reel for storing tape and/or cable during storage and/or transport.

The monitor 120 according to embodiments of the present disclosure may have dimensions (width x length x thickness) in the range of (4 cm to 8 cm) x (0.5 cm to 3 cm). The cable may have a length between 20cm and 100 cm.

The handle 110 of the attachment (cable not shown) is coupled to the rear 120B of the monitor 120 by a coupling mechanism, as will be explained below with respect to fig. 6B.

Fig. 6B illustrates a perspective view of the monitor 120 of the accessory device according to an embodiment of the present disclosure. The rear portion 120b of the monitor 120 includes a coupling mechanism 125, here embodied as a protrusion, for releasably coupling the handle 110 to the monitor 120. The coupling mechanism 125 may correspond to the shape of the connector of the catheter, such that the handle 110 may be coupled to the monitor 120 according to the same principles as coupling the catheter to the attachment tool 111. Thus, the coupling mechanism 125 may be substantially cylindrical or conical with an outer curvature corresponding to the inner curvature of the attachment means 111 of the handle 110. Thus, the monitor 120 and the handle 110 can be easily coupled to provide a compact accessory device 100, making it easy to carry the accessory device 100, and to protect the camera during storage/transportation.

The rear portion 120b of the monitor 120 can include two parallel apertures 126 configured to receive straps for securing the monitor 120 to an object (e.g., a user's leg). Alternatively, the rear portion 120b of the monitor may include an adhesive, such as a reusable adhesive, for adhering the monitor to the user's leg.

In the case where the monitor 120 is secured to an object, such as a user's leg, the coupling mechanism 125 (with the handles separated) can provide support to tilt the monitor 120, thereby providing a comfortable view for the user during the catheterization procedure.

Fig. 7 illustrates the use of the attachment 100 as described herein. The monitor 120 is secured to the user's leg 91 by a strap 127. The handle (not visible) is manipulated by the hand 92 of the user. On the display 122 of the monitor 120, the user can see her passage area 93 'and body passage 94' (e.g., the outer urethral meatus) via images/videos recorded by the camera (not visible) of the handle. Catheter 10' (as seen on display 121 of the monitor) is coupled to the attachment means of the handle so that the user can guide the tip of the catheter into the body passageway by viewing display 122. Thus, the user can avoid contaminating the sterile insertable part of the catheter and in this way can avoid infection of the urinary tract caused by such contamination. When the catheter has been inserted, e.g. before or after urination/defecation, the user can decouple the catheter from the attachment means of the handle and follow his/her preference.

Fig. 8 illustrates a schematic view of an accessory device 100 as described herein. The attachment 100 includes a handle 110 including an attachment means 111 for releasably coupling the catheter 10 (dashed lines) to the handle, and a camera 112 for capturing one or more images. Further, the accessory device 100 includes a monitor 120 that communicates with the camera 112 through a wired connection, such as by a cable 121. Further, the monitor includes a display 122 configured to display one or more images.

The camera 112 and the attachment means 111 may be fixed in a body 113 of the handle 110, for example a body having dimensions providing a hand-held handle 110. The attachment tool 111 may be configured to releasably couple the connector 13 of the catheter 10 to the handle 110, such as to extend the insertable portion 11 of the catheter 10 into free space. Preferably, attachment means 111 are provided for fixing the catheter 10 along a first catheter axis L (dash-dot line), and a camera 112 is arranged in the handle 110, for example to define a first optical axis K (dash-dot line) defining the viewing direction of the camera 112. Preferably, the first optical axis K intersects the first conduit axis as shown. Thus, the camera 112 is configured to capture images of at least some portion of the catheter 10, such as specifically the tip 12 of the catheter. Preferably, the camera 112 provides for simultaneous focusing of the tip 12 and the proximity of the tip (e.g., the channel region).

While particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and that various changes and modifications may be apparent to those skilled in the art without departing from the spirit and scope of the claimed invention. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense. The claimed invention is intended to cover all alternatives, modifications, and equivalents.

Claims

1. An attachment for assisting in the insertion of a catheter, wherein the attachment comprises

-a handle comprising attachment means for releasably coupling a catheter to the handle, and a camera for capturing one or more images; and

a monitor in communication with the camera, the monitor comprising a display configured to display the one or more images.

2. The attachment of claim 1, wherein the attachment means comprises a clip for releasably coupling a connector of a catheter to the handle.

3. The attachment of claim 2, wherein the clip is configured to secure a connector of a catheter by friction.

4. The attachment of claim 3, wherein the clip comprises a conical interior shape configured to receive and secure a connector of a catheter.

5. The attachment of any one of claims 1-4, wherein the attachment means is configured for securing the catheter along the first catheter axis.

6. An attachment according to any of claims 1 to 5, wherein the camera is fixed in the handle relative to the attachment means.

7. An attachment according to any of claims 1 to 6, wherein the camera comprises a first optical axis defining a viewing direction.

8. The attachment of claim 7 when dependent on claim 5, wherein the first optical axis intersects the first catheter axis.

9. An attachment according to claim 7 when dependent on claim 5, wherein the first optical axis intersects the first conduit axis at a distance of between 55mm and 200mm from the lens of the camera.

10. The accessory device of any one of claims 1 to 9, wherein the camera has a depth of field of at least 60mm.

11. The accessory device of any one of claims 1 to 10, wherein the accessory device further comprises a light source.

12. The attachment of claim 11, wherein the light sources are arranged circularly around the camera.

13. An accessory device according to any one of claims 11 to 12 when dependent on claim 7, wherein the light source is configured to produce a beam of light substantially parallel to the first optical axis of the camera.

14. An attachment according to any of claims 1 to 13, wherein the monitor comprises a strap for securing the monitor to an object.

15. The attachment of any one of claims 1-14, wherein the monitor includes a coupling mechanism for releasably coupling the handle to the monitor.

16. The accessory device of any one of claims 1 to 15, wherein the monitor communicates with the camera through a wired connection.

17. The accessory device of any one of claims 1 to 16, wherein the accessory device has a liquid ingress protection rating of at least IPX4 according to IEC standard 60529.

18. A catheter system for assisting in inserting a catheter, the catheter system comprising an attachment and a catheter, the catheter comprising an insertable part and a connector, the insertable part having a proximal end, wherein the attachment comprises

-a handle comprising attachment means for releasably coupling the catheter to the handle, and a camera for capturing one or more images, and

19. The catheter system of claim 18, wherein the camera is configured to focus on a proximal end of the catheter.

20. The catheter system of any one of claims 18-19, wherein the catheter is an intermittent urinary catheter.

21. A method of using the catheter system of claims 18-20, wherein the method comprises

-optionally decoupling the handle from the monitor,

-coupling the catheter to the handle,

-viewing the image captured by the camera on the monitor's display to locate the passage area and the body canal, and

-guiding the catheter close to the body tract.